Capsular contracture is a common complication following breast reconstruction or augmentation when breast implants are placed into the body. After implantation, the body forms a lining around the implant. This lining is referred to as the “capsule,” “tissue capsule” or “scar capsule”. The formation of this capsule is a natural response and occurs in response to implantation of any foreign object, including, but not limited to: breast implants, pacemakers and artificial joints.
At the time of breast augmentation or breast reconstruction surgeries, tissues are injured and the body tries to repair the defect by generating new blood vessels at the site of the injury and secretes collagen to form a new tissue matrix. This scar tissue surrounds the breast implant in the form of a spherical capsule. All implants become encapsulated. The capsule is a living tissue that the body creates in response to the foreign object, the breast implant, and thus, undergoes dynamic changes.
Clinical studies with saline-filled implants demonstrate that in about 5 to 75% of patients, the capsule contracts, most often within 6 months of surgery. The shrinking of the capsule increases the pressure within the implant and is perceived as hardening of the implant by the patient. As time goes on, patients may experience significant discomfort, pain, distortion and displacement of the implant that may require additional surgeries. Capsular contracture may happen on one or both sides and with each additional surgery, the risk of developing capsular contracture increases. It is currently impossible to predict which patient with develop capsular contracture because of its multi-factorial nature. Development of capsular contracture is related to the surface properties of the implant, the position in which the implant is inserted, the surgical technique used during insertion, whether or not anti-microbial irrigation is used, the medical history of the patient, etc. Regardless of the cause, recurrence rates of capsular contracture are high and afflicted women often undergo multiple, and frequently ineffective, secondary surgical procedures.
In order to classify the capsular contracture, a system has been developed to compare the feeling and appearance of the breast after augmentation. This system, called the Baker Classification, is widely used by plastic surgeons:
Class I: the breast feels the same as a normal breast with no hardness or change in shape.
Class II: the breast is harder and although the implant is not yet visible, it can usually be felt.
Class III: the breast is firm and tender. The implant can be seen. The shape of the breast is usually distorted.
Class IV: the breast is hard and extremely painful. The shape of the breast is abnormal.
There are two currently available treatments for capsular contracture including closed capsulotomy and open capsulotomy. In closed capsulotomy, the surgeon forcibly squeezes the implant to “pop” the scar tissue (opening it up). Breast implant manufacturers do not recommend closed capsulotomy as it can lead to possible rupture of the implant.
There are two forms of open capsulotomy surgery. In the first type, the physician surgically breaks up the scar tissue in order to release the capsule's hold on the implant without removing the scar tissue. The second type of open capsulotomy involved the surgical removal of the scar capsule. Once the capsule is broken up or removed, however, the body will form a new capsule around the breast implant and this capsule is at high risk for contracture.
Manual compression of the breast after surgery can help prevent capsular contracture. By compressing the breast implant, the surface area of the capsule is increased and, with frequent compression, the capsule will not contract, thereby allowing the implant to retain its intended shape and the breast to have a normal appearance. For best results, the compression is recommended to be performed daily for several months after surgery. One disadvantage to manual compression is the level of force the patient is capable of producing is often not sufficient to prevent capsular contracture, is not linear with respect to time and cannot be adequately controlled for safety and effectiveness.
Therefore, a medical device is needed which provides patients who have received breast implants with controlled compression forces to the breast in order to prevent capsular contracture and its undesirable consequences.